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EP0881909A1 - Activateur tissulaire du plasminogene recombine (rtpa) pour la prevention de la cataracte secondaire apres une operation de cataracte - Google Patents

Activateur tissulaire du plasminogene recombine (rtpa) pour la prevention de la cataracte secondaire apres une operation de cataracte

Info

Publication number
EP0881909A1
EP0881909A1 EP97905042A EP97905042A EP0881909A1 EP 0881909 A1 EP0881909 A1 EP 0881909A1 EP 97905042 A EP97905042 A EP 97905042A EP 97905042 A EP97905042 A EP 97905042A EP 0881909 A1 EP0881909 A1 EP 0881909A1
Authority
EP
European Patent Office
Prior art keywords
fibrosis
rtpa
prevention
proliferation
posterior capsule
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP97905042A
Other languages
German (de)
English (en)
Inventor
Hannes-Edgar Kompa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alcon Pharmaceuticals Ltd
Alcon Deutschland GmbH
Original Assignee
Alcon Pharmaceuticals Ltd
Alcon Pharma GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alcon Pharmaceuticals Ltd, Alcon Pharma GmbH filed Critical Alcon Pharmaceuticals Ltd
Publication of EP0881909A1 publication Critical patent/EP0881909A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/49—Urokinase; Tissue plasminogen activator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/12—Ophthalmic agents for cataracts

Definitions

  • the present invention relates to the use of rt-PA for the prevention of postoperative proliferation of lens tissue on the posterior capsule wall (fibrosis) in the case of extracapsular cataract extraction.
  • the fibrosis of the posterior capsule wall also called connective tissue proliferation, is the most common late complication of extracapsular cataract extraction (Z. Prakt. Augenheilkd. 15, 488 (1994)). In 35-51% of cases, follow-up treatment is necessary within 5 years.
  • cystoid macular edema and rubeosis iridis MC Boschi et al., New Trends Ophthalmol., 9 (1), 55-57 (1994); D. Altamirano et al., Klin. Monatbl. Augenheilkd., 204 (5), 286-287 (1994)).
  • t-PA is the main cause of the episcleral fibrosis (discoloration) of the filter pad after trabeculectomy (glaucoma operation) for the failure of this therapy, significantly decreased.
  • a drainage fistula (filter cushion) is placed through the conjunctiva, which, however, clogs up again as a result of fibroblast proliferation.
  • the authors cite the inhibition of the formation of a primary fibrin / fibronectin matrix as a probable cause for the successful prevention of this complication by t-PA, which may function as a framework for the subsequent fibrosis.
  • EP-A-0 318 801 describes that rt-PA prevents the formation of adhesions of organs or parts of organs after invasive interventions in the chest or abdominal cavity.
  • the present invention thus relates to the use of rt-PA for the prevention of the fibrosis of the posterior capsule wall known as the afterstar after extracapsular cataract extraction.
  • the reduction in fibrosis is associated with an improvement in vision.
  • Another object of the invention is the use of rt-PA for the manufacture of a medicament for the prevention of the night star.
  • isoforms or mutants derived therefrom can also be used, provided that they have comparable fibrinolytic activity.
  • Isoforms or mutants are understood to mean those forms which, in addition to the native structure, contain one or more amino acids, differ in the amino acid sequence with respect to one or more amino acids from the naturally occurring t-PA (ie have a heterologous amino acid sequence), or in which one or more amino acids which are present in the natural t-PA are not present, and their glycosylated and non-glycosylated derivatives.
  • Rt-PA is applied postoperatively, with an amount of 1-20 ⁇ g preferably instilled into the anterior chamber by paracentesis or administered subconjunctivally.
  • rt-PA is present as a lyophilisate for the solution, an aqueous arginine / polysorbate buffer being used as the solvent.
  • concentration of the effective dose after reconstitution of the solution is 1-20 ⁇ g rt-PA in 0.01-0.1 ml per injection.
  • a suitable medicament for the prevention of the fibrosis of the posterior capsule wall known as the afterstar after extracapsular cataract extraction contains for example in one unit the fibrinolytic rt-PA as a lyophilisate in an amount of 0.10-0.50 mg, preferably together with stabilizers or buffers such as arginine, phosphoric acid and Polysorbate 80, and in a second unit as a diluent, 2 to 6 ml of an aqueous 0.1-0.3 M arginine / polysorbate buffer, advantageously prefilled into a syringe, so that after reconstitution of the rt-PA solution, the fibrinolytic in a concentration from 0.05 to 0.2 mg / ml.
  • a dose of 1-20 ⁇ g rt-PA is applied from this solution by injection of a corresponding volume of the reconstituted solution.
  • the lyophilisate preferably contains 0.3 mg of rt-PA and 3 ml of 0.2M arginine / phosphate buffer with a pH of 7.3 are preferably used as diluent.
  • the preferred application amount is 10 ⁇ g rt-PA in 100 ⁇ l of the buffer mentioned.
  • the effect of a single dose of rt-PA on the incidence of fibrosis of the posterior capsule wall after extracapsular cataract extraction was examined in a clinical study.
  • the investigations were carried out in a randomized, double-blind, parallel group study.
  • the dose unit of 10 ⁇ g rt-PA was available as a solution in 100 ⁇ l 0.2 M arginine buffer, and 100 ⁇ l 0.2 M arginine buffer alone was used as placebo.
  • the lyophilisate then has the following composition
  • diluent 3 ml of sterile 0 2 M arginine / phosphate buffer are filled into a 3 ml syringe as diluent.
  • the diluent has the following composition
  • the product After reconstitution of the lyophilizate with 3 ml of the diluent, the product has the following composition
  • solution 100 ⁇ l, which contain 0.01 mg rt-PA, are administered intraocularly.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne l'utilisation d'activateur tissulaire du plasminogène recombiné (RTPA) pour la prévention de la prolifération post-opératoire des tissus cristalliniens, connue sous le nom de cataracte secondaire, sur la paroi capsulaire postérieure (fibrose), après extraction extracapsulaire de la cataracte.
EP97905042A 1996-02-22 1997-02-18 Activateur tissulaire du plasminogene recombine (rtpa) pour la prevention de la cataracte secondaire apres une operation de cataracte Withdrawn EP0881909A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19606551 1996-02-22
DE19606551A DE19606551C2 (de) 1996-02-22 1996-02-22 rt-PA zur Prävention des Nachstars nach Kataraktoperation
PCT/EP1997/000756 WO1997030724A1 (fr) 1996-02-22 1997-02-18 Activateur tissulaire du plasminogene recombine (rtpa) pour la prevention de la cataracte secondaire apres une operation de cataracte

Publications (1)

Publication Number Publication Date
EP0881909A1 true EP0881909A1 (fr) 1998-12-09

Family

ID=7786075

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97905042A Withdrawn EP0881909A1 (fr) 1996-02-22 1997-02-18 Activateur tissulaire du plasminogene recombine (rtpa) pour la prevention de la cataracte secondaire apres une operation de cataracte

Country Status (7)

Country Link
EP (1) EP0881909A1 (fr)
JP (1) JP2000504737A (fr)
AR (1) AR005949A1 (fr)
AU (1) AU1874197A (fr)
CA (1) CA2247460A1 (fr)
DE (1) DE19606551C2 (fr)
WO (1) WO1997030724A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002502821A (ja) * 1998-02-04 2002-01-29 潔 岡田 水晶体上皮細胞を除去し後発白内障を防ぐための医薬製剤とその使用方法

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2483234A2 (fr) * 1980-05-29 1981-12-04 Fabre Sa Pierre Composition ophtalmique contenant un activateur du plasminogene
US4777043A (en) * 1985-12-17 1988-10-11 Genentech, Inc. Stabilized human tissue plasminogen activator compositions
JPH0640943A (ja) * 1991-04-22 1994-02-15 Senju Pharmaceut Co Ltd 眼内手術用剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9730724A1 *

Also Published As

Publication number Publication date
WO1997030724A1 (fr) 1997-08-28
DE19606551C2 (de) 2000-06-08
AR005949A1 (es) 1999-07-21
AU1874197A (en) 1997-09-10
JP2000504737A (ja) 2000-04-18
CA2247460A1 (fr) 1997-08-28
DE19606551A1 (de) 1997-08-28

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